Method and apparatus for connecting a compatibility liner with a source of perishable therapeutic

ABSTRACT

Method and apparatus for connecting a compatibility liner with a source of perishable therapeutic is provided. In one exemplary system for connecting a reservoir of perishable therapeutic with a lumen, a hollow hub having a first end and a second end is provided. The first end of the hollow hub, which contains a bond port, is in fluid communication with the second end. The second end of the hollow hub may contain a docking groove that is sized to couple a reservoir to it. The system also includes an inner hypo-tube having a proximal tip and an inner lumen. This inner lumen is lined with a therapeutic compatible lining and is in fluid communication with the second end of the hub through the proximal tip of the inner hypo-tube. The inner lining and the proximal tip in this system are configured to shield therapeutic ejected from the reservoir from contacting materials that can diminish the integrity of the therapeutic.

FIELD OF THE INVENTION

[0001] The present invention relates to the transport of perishabletherapeutics from a storage reservoir to a target site. Morespecifically the present invention relates to method and apparatus foreffectively connecting a reservoir of perishable therapeutic to a lumenthat is lined with a material compatible with the perishabletherapeutic.

BACKGROUND OF THE INVENTION

[0002] The delivery of therapeutics to a target site in the body of apatient is a task that finds innumerable applications in the practice ofmodem medicine. In some applications the therapeutic may be deliveredthrough a needle and syringe while in others the therapeutic may bedelivered though a pump and catheter system. In either of theseconfigurations, as with the many other plausible configurations, theobjective is to deliver active therapeutic to a target site such thatthe therapeutic may cure the infirmities resident at the target site.For some perishable, sensitive or volatile therapeutics, such as certainviruses employed today, a compatibility issue can arise between thetherapeutic and the channel or vessel that will transport thetherapeutic from its storage vessel to its target site. Whencompatibility issues do arise between the therapeutic and itssurroundings, the therapeutic may loose some or all of its effectivenessand may, upon its arrival at the target site, be partially or completelyinert. In certain applications, the therapeutic may loose itseffectiveness moments before it is delivered as it passes down andthrough the delivery lumen of the delivery device simply because thetherapeutic has come in contact with a non-compatible material.

[0003] Therefore, the environment in which the therapeutic is stored aswell as the environment in which the therapeutic must travel can anddoes affect the potency and effectiveness of certain perishabletherapeutics. In order to avoid the risk of deterioration of the potencyof perishable therapeutics it is, consequently, advantageous to minimizeor eliminate the contact between non-compatible materials and thetherapeutic during the delivery of the therapeutic to the target site.

SUMMARY OF THE INVENTION

[0004] The present invention includes the proper handling of perishabletherapeutic. In one embodiment a system for connecting a reservoir ofperishable therapeutic with a lumen is provided. This embodiment has ahollow hub having a first end and a second end. The first end of thehollow hub, which contains a bond port, is in fluid communication withthe second end of the hollow hub. The second end of the hollow hub inthis embodiment may contain a docking groove that is sized to couple areservoir to it. This embodiment also includes an inner hypo-tube havinga proximal tip and an inner lumen. The inner lumen may be lined with aperishable therapeutic compatible lining and may be in fluidcommunication with the second end of the hub through the proximal tip ofthe inner hypo-tube. The inner lining and the proximal tip may beconfigured to shield perishable therapeutic, ejected from the reservoirand present within the second end, from materials that arenon-compatible with the therapeutic.

[0005] In a second embodiment a method for coupling a reservoir ofperishable therapeutic to a lumen lined with a therapeutic compatiblelining is provided. This method includes inserting the proximal end of amanifold hypo-tube into a first end of a hub, the hub also having asecond end; placing the proximal end of an inner hypo-tube within theproximal end of the manifold hypo-tube and urging the proximal end ofthe inner hypo-tube through the proximal end of the manifold hypo-tubeuntil the proximal end of the inner hypo-tube comes in contact with astopping point in the hub. In this second embodiment the tip of theproximal end of the inner hypo-tube may be covered in a therapeuticcompatible material and the inner surface of the inner hypo-tube may becovered with a therapeutic compatible lining.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006]FIG. 1 is a side sectional view of the proximal end of aconcentric hypo-tube assembly employed in an embodiment of the presentinvention.

[0007]FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. 1.

[0008]FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 1.

[0009]FIG. 4 is a side sectional view of the proximal end of aconcentric hypo-tube assembly in accordance with an alternativeembodiment of the present invention.

[0010]FIG. 5 is a side sectional view of the proximal end of aconcentric hypo-tube assembly in accordance with another alternativeembodiment of the present invention.

[0011]FIG. 6 is an enlarged sectional view of the proximal end of theconcentric hypo-tube assembly as employed in the embodiment illustratedin FIG. 5.

DETAILED DESCRIPTION

[0012] As described and used herein a “perishable therapeutic” includesa therapeutic whose efficiency can be diminished through the contactwith specific non-compatible compounds or materials. These perishabletherapeutics include adenoviral vectors; adeno-associated vectors;certain proteins including basic fibroblast growth factors; certainnucleic acids such as DNA plasmid; and, certain cells such as myoblasts,fibroblasts, and stems cells. Thus, regarding these examples, when theseperishable therapeutics come in contact with stainless steel, forexample, they loose some or all of their effectiveness as a therapeutic.This list of perishable therapeutics is not exhaustive but, instead, ismeant to be exemplary of therapeutics that may loose some or all oftheir healing effectiveness once placed in proximity to a specificnon-compatible material.

[0013] As described and used herein a “perishable therapeutic compatiblelining” includes a lining that does not substantially retard theeffectiveness of an otherwise perishable therapeutic. It may include aspecific coating applied to a material as well as a separate materialthat is later adhered or placed adjacent to the underlying material thatit lines. One primary purpose of this lining is to retard thedegradation of therapeutic that comes in contact with it. While thelining may modify the effectiveness of the therapeutic it does so at alesser rate than that of the material that it covers and would otherwisecome in contact with the therapeutic.

[0014] As described and used herein “non-compatible” is an adjectiveused to describe materials that more than insubstantially effect thepotency or effectiveness of a therapeutic. When quantified this mayinclude materials that reduce a therapeutic's efficiency byapproximately 10% through and including an entire 100% reduction in itseffectiveness, thereby making the use of the therapeutic, after comingin contact with the non-compatible material, an inconsequential event.

[0015]FIG. 1 is a side sectional view of a concentric hypo-tube assembly150 and hub 10 in accordance with one embodiment of the presentinvention. In FIG. 1 the hub 10 and the proximal end of the concentrichypo-tube assembly 150 are clearly evident. As can be seen the hub 10may be shaped in the form of an hour-glass with a longer end 130connected to a female luer connection 110 through a channel 145 having astopping point 120. The hub 10 in FIG. 1 contains a hub wall 11 whichmay be manufactured from a single material such as a polypropylene, apolycarbonate or any other material that is rigid and compatible withthe perishable therapeutics that may be delivered by the hypo-tubeassembly 150. Alternatively, should this material not be compatible withthe therapeutic it may be lined with a material that is.

[0016] As can be seen, the female luer connection 110 contains threadsor grooves 12, which are illustrated in FIG. 1 as angled dashed linesencircling the interior surface of the female luer connection 110. Thesegrooves 12 and the female luer connection 110 may be dimensioned so asto accept and secure a removable reservoir (which is not shown)containing perishable therapeutic. This perishable therapeutic may beinjected down through the concentric hypo-tube assembly 150 to a targetsite within the body by depressing a syringe (not shown) integrated withthe removable reservoir. As can be seen, a threaded reservoir containingthe therapeutic may be readily attached to the female luer connection110 by aligning and screwing the reservoir into the connection 110.

[0017] As is evident the proximal end of a manifold hypo-tube 17 and theproximal end of an inner hypo-tube 18 are located within the longer end130 of the hub 10. The manifold hypo-tube 17 and the inner hypo-tube 18may be designed for numerous medical applications. They may be designedto be part of an injection catheter used to inject perishabletherapeutic into the heart or other dense tissue area of a patient. Theymay also be designed to be implanted in the body and used for long-termdelivery of a therapeutic. When used for puncturing applications thehypo-tubes may be made from stainless steel or other suitably rigidmaterials. Conversely, when used in less stress-intensive applicationsthe hypo-tubes may be made from less rigid materials such as plastic.

[0018] In this particular embodiment the manifold hypo-tube 17 is madefrom stainless steel and is attached to a spring mechanism of aninjection catheter (not shown) which is used to inject a needle into theheart or cardiopulmonary sac of a patient. Once the needle is injectedinto the heart or cardiopulmonary sac the inner hypo-tube 18, alsostainless steel, would be used to carry therapeutic to the targeted siteof the body.

[0019] In this embodiment the inner hypo-tube 18 contains a liner 104,which may be made from polyether block-amide (one example of which isPebax™ 5533) or any other material that is compatible with a perishabletherapeutic that may contact the liner 104. The proximal end of theinner hypo-tube 18 in this embodiment has a collar 19 adjacent to it.This collar 19 may be made from the same material as the liner or it maybe made from another material as long as the second material is alsocompatible with the perishable therapeutic that may come in contact withit. The collar 19, made from a therapeutically compatible material, maybe sized to compressibly secure or press-fit itself to the stoppingpoint 120 located within the channel 145 of the hub 10. In thisembodiment the liner 104 extends out of the inner hypo-tube and throughthe collar 19 to line the interior lumen of the collar. Therefore, whenthe inner hypo-tube is being manufactured the liner 104 may beprotruding from the proximal end of the hypo-tube and may be covered byor threaded through the collar such that the liner 104 lines theinterior lumen of the collar.

[0020] In this embodiment the inside diameter of the lumen in the innerhypo-tube 18 may be about 0.0130 inches and the outside diameter of theinner hypo-tube 18 may be about 0.0250 inches. The inside diameter ofthe liner 104 may be 0.0075 inches. Other sizes and dimensions are alsoplausible.

[0021] The stopping point 120 of the hub 10 in this embodiment is sizedsuch that it may snugly secure the collar 19 to the hub 10 after thecollar 19 has been pushed or urged toward the stopping point 120. Inother words, the use of friction and the proper sizing of the dimensionsbetween the stopping point 120 and the collar 19 create a mechanicaladhesion or press-fit that couples the collar 19 to the hub 10 at thestopping point 120 and prevents over-wicking of adhesive 102.

[0022] The hub wall 11 also contains a plurality of bond ports. In thisfigure a first bond port 14 is shown in the channel 145 of the hub 10while a second bond port 15 is shown on the longer end 130 of the hub10. These bond ports may have a funnel-like configuration and mayprovide an access via from outside the hub to inside the hub to allowadhesive or other material to be injected from outside the hub 10 atdifferent points along the hub 10.

[0023] In FIG. 1 an adhesive 102 is shown after being injected into thehub 10 through the first bond port 14 and the second bond port 15 tosecure the inner hypo-tube 18 and the manifold hypo-tube 17 to eachother and to the hub 10. As is evident the adhesive 102 surrounds theproximal end of the inner hypo-tube 18 as well as the proximal end ofthe manifold hypo-tube 17 but has not wicked past the stopping point 120between the collar 19 and the hub 10. In practice it is preferred thatthe amount of adhesive injected into the hub is controlled such that noadhesive wicks past the stopping point 120 and, consequently, riskscoming in contact with therapeutic that may be injected down the lumenof the inner hypo-tube. The adhesive employed in this embodiment may beH. B. Fuller adhesive no. 3507 and Tra-con FDA2.

[0024] Other features of the hub 10 illustrated in FIG. 1 are thereinforcing nub 16 and the wing 13. These two components extend from thetubular hourglass-designed hub 10 and allow the hub 10 to be grasped androtated as required. For example, when a threaded reservoir oftherapeutic needs to be screwed or coupled into the female luerconnection 110 of the hub 10, the wings 13 can be grasped by an operatorand used to rotate the hub 10 to couple the hub 10 to the therapeuticreservoir (not shown).

[0025] In manufacturing the device illustrated in FIG. 1, a manufacturermay first gather the components to be assembled. These components wouldinclude the inner hypo-tube 18, the manifold hypo-tube 17, and the hub10. As a first step the manufacturer may insert the proximal or near endof the manifold hypo-tube 17 into the longer end 130 of the hub 10. Theproximal end of the manifold hypo-tube 17 may be completely insertedinto the longer end 130 of the hub 10 until it touches an interior hub10 wall or, alternatively, until it is located near an interior hub 10wall. Whether or not the proximal end of the manifold hypo-tube touchesan interior wall may be determined by the placement of the bond portsbecause adhesive injected through the bond ports may be obstructed fromreaching the interior surfaces of the manifold hypo-tube if theplacement of the manifold hypo-tube 17, within the hub 10, obstructs thebond ports. While the distance that the proximal end of the manifoldhypo-tube 17 may be inserted into the hub 10 can vary, it is preferredthat the proximal end of the manifold hypo-tube 17 does not touch aninterior hub wall 11 so that adhesive injected into the second bond port15 may flow both inside and outside of the manifold hypo-tube 17. Shouldthe manifold hypo-tube 17 come in contact with the hub wall, adhesiveinjected through the second bond port 15 may be deterred from travelingcompletely in and around the proximal end of the manifold hypo-tube 17.Once the proximal end of the manifold hypo-tube 17 is inserted into thehub 10, the proximal or near end of the inner hypo-tube 18, may beplaced within the manifold hypo-tube 17 and into the hub 10.

[0026] As can be seen in FIG. 1 the proximal end of the inner hypo-tubehas a collar 19 adjacent to its tip. This collar may be manufacturedfrom the same material as the liner or any other material compatiblewith the perishable therapeutic that may be delivered by the device. Thecollar may be manufactured by extending the lining material, which linesthe inner lumen of the inner hypo-tube 18, 0.500 inches past the tip ofthe inner hypo-tube 18 and, then, by building or wrapping the collarmaterial around the protruding lining material such that, uponcompletion, the collar is connected to the lumen material and containsan inner lumen of lining material seamlessly connected to the innerhypo-tube. Care should be taken when manufacturing the collar to avoidcollapsing the lumen within the liner. Once the collar is manufactured,it should preferably be allowed to cure for 12 hours before it istrimmed. Care should also be taken here, as with the other portions ofthe assembly process, not to kink, force or otherwise twist the variouscomponents. In addition, an assembler should continually verify that noadhesive has entered or has otherwise come in contact with the lumen 101of the liner 104.

[0027] The inner hypo-tube 18 along with collar 19 may then becompletely inserted into the hub 10 until the collar 19 comes in contactwith the stopping point 120 located within the channel 145 of the hub10. Once the collar 19 reaches the stopping point 120, an additionalaxial force may be placed on the inner hypo-tube 18 to further urge orpress-fit the collar 19 into the stopping point 120. The collar 19,which may be made from Pebax™ 5533, may be soft and compressible so thatit readily deforms under the additional axial load and securely contactsthe stopping point 120 to provide a holding force to retain the collar19 against the stopping point 120.

[0028] After the hypo-tubes have been inserted and properly positionedwithin the longer end 130 of the hub 10 adhesive may be injected intothe bond ports. Adhesive may first be injected into the first bond port14 such that it surrounds the proximal end of the inner hypo-tube 18 andthe collar 19 and the adhesive may then be injected into the second bondport to surround the proximal end of the manifold hypo-tube 17. Theadhesive injected in the first bond port may cement and lock the innerhypo-tube 18 to the hub 10 and the collar 19 to the tip of the innerhypo-tube 18. It may also provide a bulwark for preventing the unwantedseepage of therapeutic past the collar 19 and down into the larger end130 of the hub 10. The adhesive may be manufactured by mixing thecomponents by hand for a minimum of 2 minutes to ensure that there is aconsistent color in the adhesive. It may then be delivered by placing itin a syringe for injection through the bond ports into the hub.

[0029] After adhesive is injected into the first bond port 14 it may beinjected, into the second bond port 15 to further secure the hypo-tubesto themselves and to the surrounding hub. Excessive adhesive should beremoved from the surface of the hub. After the adhesive is allowed tocure, for preferably 12 hours, a 30x microscope may be used to verify a1 mm bond length between the inner hypo-tube 18 and the hub 10 andbetween the outer hypo-tube 17 and the hub 10.

[0030]FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. 1that illustrates the liner 104, the hub wall 11, the liner lumen 101,the manifold hypo-tube 17, and the inner hypo-tube 18. As can be seen,FIG. 2 illustrates that the longer end 130 of the hub 10 as well as thevarious lumens and hypo-tubes each have a circular cross-section andthat they may be concentrically located about one another. Whileconcentric circular cross-sections are shown in this embodiment otherconfigurations and cross-sections may also be employed. For example,these cross-sections may also be hexagonal, square, and any othercross-section required by the specific application. Moreover, they maynot be equally spaced about the same axis but may, instead, be locatedat different distances from a reference longitudinal axis.

[0031] In FIG. 2 the liner 104 is shown as not being in contact with theinner hypo-tube 18, it is preferred, however, that the liner 104 shouldbe in contact with the inner hypo-tube 18 so that the liner 104 mayreceive structural support from the inside surface of the innerhypo-tube 18 and so that the lumen may have the largest cross-sectionalarea possible.

[0032]FIG. 3 is a sectional view of a cross-section taken along line 3-3of FIG. 1. As can be seen, the wings 13 protrude outwardly from the hubwall 11 and are aligned 180 degrees from one another. As can also beseen, the collar 19 is in direct contact with the inner surface of thehub wall 11 as well as with the liner 104. It is through this directcontact with the inner surface of the hub that adhesive injected intothe hub at bond ports 14 and 15 is prevented from wicking past and intothe female luer connection 110 side of the hub 10. Liner lumen 101 isalso evident in FIG. 3.

[0033]FIG. 4 illustrates a sectional view of an alternative embodimentof the present invention. In FIG. 4 a hub 40 and hypo-tube assembly 420are shown. The hub 40 has a female luer connection 400 having grooves 42as well as reinforcing nubs 46, wings 43, a first bond port 44, a secondbond port 45, a hub wall 41, and a stopping point 410. The hypo-tubeassembly 420 includes a manifold hypo-tube 47, an inner hypo-tube 48, aliner 404, a liner lumen 401, and a collar 49 adjacent to the innerhypo-tube 48. The collar 49 has a heat shrink material 405 placed at itsend. This heat shrink material 405 may be made from Teflon™ while thecollar may be made from a material that is compatible with a perishabletherapeutic, and the hypo-tubes may be made from stainless steel. Thehub wall 41 may be homogeneously manufactured from a plastic or othersufficiently rigid material.

[0034] As is evident, the proximal end of the inner hypo-tube 48 in thisembodiment has been inserted into the hub 40. However, rather thanhaving a silo-shaped collar, as described in the first embodiment, thecollar 49 in this embodiment has been covered or otherwise treated witha Teflon™ heat shrink which acts to constrict the outer diameter of thecollar and provide a flush and snug fit between the collar 49 and thestopping point 410 of the hub 40.

[0035] In order to secure the collar 49 to the hub 40, heat should firstbe applied to the tip of the collar 49, which contains the Teflon™ heatshrink. The tip of the collar 49 containing the heat shrink will thenshrink or constrict under the forces of the heat shrink to a size thatclosely matches the dimensions of the stopping point 410 of the hub 40.A close dimensional alignment between the tip of the collar 49 and thestopping point 410 will provide a good sealing engagement between thecollar and the hub. A benefit of a good sealing engagement is thattherapeutic threaded into the female luer connection 400 and injectedinto the liner lumen 401 will be prevented from passing the interfacepoint between the collar 49 and the stopping point 410 and contactingmaterials that are not compatible with the therapeutic. To furthersecure the inner hypo-tube 48 to the stopping point 410, and the otherhypo-tube assembly 420 components to the interior of the hub 40, anadhesive should be injected into the first bond port 44 and the secondbond port 45 in this embodiment.

[0036]FIG. 5 illustrates a side sectional view of another alternativeembodiment of the present invention. Rather than using the collars 19and 49 described above, the embodiment illustrated in FIG. 5 uses aflared funnel-shaped liner end 506 to facilitate the clean contact andcommunication between therapeutic placed in the female luer connection500 and the lumen 501 located within the inner hypo-tube 58.

[0037] In FIG. 5 a hub 50 and hypo-tube assembly 530 are illustrated.This hub 50 along with the hypo-tube assembly 530 are shown in sectionalview consistent with the illustrations provided in FIGS. 1 and 4 above.This hub 50 contains a hub wall 51, the hub wall 51 having a first bondport 54, a second bond port 55, and a third bond port 59 wherein eachbond port is conically shaped and provides a passage from the exteriorof the hub 50 to the interior of the hub 50. These bond ports provideaccess for adhesive to be injected into the hub during the assembly ofthe device.

[0038] Similar to the embodiments described above, the hub wall 51contains reinforcing nubs 56 and wings 53. These reinforcing nubs 56 andthe wings 53 are used to help grasp and secure components to the femaleluer connection 500 of the hub 50. This female luer connection 500located at one end of the hub 50 is used to connect other components tothe hub 50. This female luer connection 500 contains grooves 52 residentwithin the inside walls of the female luer connection 500.

[0039] Also evident in FIG. 5 are a liner 504, a liner lumen 501, aninner hypo-tube 58, and a manifold hypo-tube 57. In this embodiment,rather than having the collar touch the stopping point of the hub 50 asin the above embodiments, the proximal end of the inner hypo-tube 58comes in contact with the stopping point 508 of the hub 50 and the liner501 extends past the end of the inner hypo-tube 58 into the female luerconnection 500 of the hub 50. The liner 504 extending into the femaleluer connection 500 in this embodiment has a liner flared end 506located at its most proximal end and a liner rim 507. The liner flaredend 506 and liner rim 507 extend into the female luer connection 500 andrest up against the hub wall 51. In order to secure this distended linersection to a hub wall 11 adhesive 502 may be injected behind the liner504 through the third bond port 59 to secure the liner in place.However, when adhesive is injected into the connection it is preferredthat the amount of adhesive is limited such that the adhesive does notwick past the liner rim 507 of the liner 504 and be placed at risk ofcontacting therapeutic that may be injected into the lumen 501.

[0040] In use, when a source of therapeutic is secured or threaded intothe female luer connection 500, as the therapeutic is forced down intothe lined lumen, the liner flared end 506 and the liner rim 507 may bepressed against the hub wall 51, thereby contributing to a secure andtight contact point between the liner and the hub wall.

[0041]FIG. 6 is an enlarged view of the stopping point 508 of the hub 50from FIG. 5. As is clearly evident in this embodiment adhesive 502 hasbeen injected and is securing the inner hypo-tube rim 508, the liner 504and the liner flared end 506. As can also be seen, the adhesive 502,while resident in, around, and between the inner hypo-tube, the hub, andthe liner 504, does not extend past the liner rim 507. As mentionedabove, it is preferable that the adhesive 502 does not extend past theliner rim 507 such that the potential contact between therapeutic andnon-compatible materials such as the adhesive 502 may be minimized ifnot eliminated.

[0042] Target sites that may be treated by the various embodiments ofthe present invention include any mammalian tissue or organ, whetherinjected in vivo or ex vivo. Non-limiting examples include heart, lung,brain, liver, skeletal muscle, smooth muscle, kidney, bladder,intestines, stomach, pancreas, ovary, prostate, eye, tumors, cartilageand bone.

[0043] Therapeutics that may be employed in the various embodiments ofthe present invention include: adenoviral vectors; adeno-associatedvectors; certain proteins including basic fibroblast growth factors;certain nucleic acids such as DNA plasmid; and, certain cells such asmyoblasts, fibroblasts, and sterns cells.

[0044] As will be understood by one of skill in the art, while variousembodiments of the present invention have been presented, numerous otherembodiments are also plausible. For example, rather than having theflared end of the liner protruding into the female luer connection ofthe hub the liner may instead wrap around and cover the inner hypo-tuberim which is then press-fit into the stopping point of the hub to form afluid tight connection. Consequently, the disclosed embodiments areillustrative of the various ways in which the present invention may bepracticed and other embodiments may be implemented by those skilled inthe art without departing from the spirit and scope of the presentinvention.

What is claimed is:
 1. A system for connecting a reservoir of perishabletherapeutic with a lumen comprising: a hollow hub with an interiorsurface, the hollow hub having a first end and a second end, the firstend in fluid communication with the second end, the first end containingat least one bond port, the second end containing a docking groove, thedocking groove sized to couple the reservoir to the second end; and aninner hypo-tube, the inner hypo-tube having a proximal tip and an innerlumen, the inner lumen being lined with a perishable therapeuticcompatible lining, the inner lumen in fluid communication with thesecond end through the proximal tip, the lining and the proximal tipconfigured to shield perishable therapeutic, ejected from the reservoirand present within the second end, from contacting materials that arenon-compatible with the therapeutic as the perishable therapeutic entersthe inner lumen.
 2. The system of claim 1 wherein the proximal tip is incontact with the interior surface of the hub and wherein the liningextends past the proximal tip into the second end and forms afunnel-like shape.
 3. The system of claim 1 wherein the proximal tip isin contact with a collar containing a perishable therapeutic compatiblematerial and wherein the collar is in contact with the interior surfaceof the hub, the collar containing a passage in fluid communication withthe inner lumen and the second end.
 4. The system of claim 1 furthercomprising: a wing, the wing protruding from an outside surface of thehub.
 5. The system of claim 4 wherein the wing contains a reinforcingnub formed on the exterior surface of the hub and wherein the exteriorsurface of the hub is in the shape of an hour-glass.
 6. The system ofclaim 1 wherein the lining extends over and covers the tip.
 7. A methodfor coupling a reservoir of perishable therapeutic to a lumen lined witha therapeutic compatible lining comprising: inserting the proximal endof a manifold hypo-tube into a first end of a hub, the hub also having asecond end; placing the proximal end of an inner hypo-tube within theproximal end of the manifold hypo-tube; and urging the proximal end ofthe inner hypo-tube through the proximal end of the manifold hypo-tubeuntil the proximal end of the inner hypo-tube comes in contact with astopping point in the hub, wherein the tip of the proximal end of theinner hypo-tube is covered in a therapeutic compatible material, andwherein the inner surface of the inner hypo-tube is covered with atherapeutic compatible lining.
 8. The method of claim 7 furthercomprising: injecting adhesive into the hub, the adhesive contacting theproximal end of the manifold hypo-tube, the proximal end of the innerhypo-tube, and an interior surface of the hub.
 9. The method of claim 7wherein the second end of the hub has a docking groove sized to couple areservoir containing perishable therapeutic to the hub.
 10. The methodof claim 9 further comprising: placing a reservoir containing perishabletherapeutic in fluid communication with the second end of the hub.
 11. Asystem for connecting a reservoir of perishable therapeutic to a lumenlined with a therapeutic compatible liner comprising: a tubular hubhaving a first end and a second end, the second end containing a dockinggroove; a manifold hypo-tube having a proximal end, the proximal endinserted into the first end of the tubular hub; and an inner hypo-tube,the inner hypo-tube having a near end, the near end having a tip, theinner hypo-tube being lined with a therapeutic compatible liner, thenear end of the inner hypo-tube being located within the proximal end ofthe manifold hypo-tube, and the near end of the inner hypo-tube beingpress-fit into the hub.
 12. The system of claim 11 wherein a collar oftherapeutic compatible material in contact with the tip of the near endof the inner hypo-tube.
 13. The system of claim 11 wherein thetherapeutic compatible liner extends out of the near end of the innerhypo-tube and covers the tip of the near end of the inner hypo-tube. 14.The system of claim 11 wherein the tubular hub is in the shape of anhour-glass, the first end in communication with the second end through achannel having a diameter smaller than the diameter of the first end andsmaller than the diameter of the second end.
 15. The system of claim 14wherein the therapeutic compatible liner extends out of the near end ofthe inner hypo-tube, through the channel and into the second end of thehub.
 16. A method of manufacturing a coupling for joining the proximalend of a hypo-tube with a reservoir of perishable therapeutic: insertingthe proximal end of the hypo-tube into the first end of a hub, theproximal end of the hypo-tube having a tip, the hub having a second end;urging the proximal end of the hypo-tube to a stop point located withinthe hub; and pressing the proximal end of the hypo-tube against the stoppoint located within the hub to affix the hypo-tube to the hub, thesecond end of the hub adapted to receive a reservoir of perishabletherapeutic, and the hypo-tube containing a therapeutic compatiblelining.
 17. The method of claim 16 further comprising: injecting anadhesive between an outside wall of the proximate end of the hypo-tubeand an inside wall of the first end of the hub.
 18. The method of claim16 wherein the tip of the proximal end of the hypo-tube has a collarmade with therapeutic compatible material.
 19. The method of claim 18further comprising: heating the collar connected to the proximal end ofthe hypo-tube.
 20. The method of claim 16 wherein the hypo-tube containsstainless-steel.
 21. The method of claim 16 wherein the tip of theproximal end of the hypo-tube has a funnel shaped protrusion of liningmaterial extending from it.